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from Mancini @FT: @NIH's vital coronavirus vaccine patent gives the US government powerful leverage over COVID-19 vaccine makers, especially Moderna. The US govt could use the patent, w/ other leverage, to compel Moderna to share its trade secrets w/ the world. 1/ 
https://twitter.com/donatopmancini/status/1384798661234855936
Why are COVID-19 vaccines scarce? Multiple reasons, but a critical reason is trade secrecy. 2 pharmaceutical companies, Moderna & BioNTech, fiercely guard, as trade secrets, the recipes for making the only two FDA-authorized mRNA-based COVID-19 vaccines.2/ https://science.sciencemag.org/content/369/6506/912/
Both companiesâ scientists & engineers did incredible work to develop the vaccines. But now, as Modernaâs & BioNTechâs shareholders & executives profit from ongoing crisis, they protect their secrets carefully, sharing only w/ a few trusted partners. 3/ https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-additional-capital-investments-increase-global
In the meantime, most of the world waits for COVID-19 vaccines, and the virus continues to spread, mutate, and kill. Under "vaccine apartheid," some people will wait until 2024 for a vaccine, meaning millions more COVID deaths and many new variants. 4/ https://www.theguardian.com/world/2021/mar/30/coronavirus-vaccine-distribution-global-disparity
If we leave control of COVID-19 vaccines in the hands of drug companies, we may get perpetual disease & death, w/ waves of new variants. Pfizer's CFO just told investors that Pfizer-BioNTech see "significant opportunity" in COVID becoming endemic. 5/ https://twitter.com/lhfang/status/1371595466664636425
Similarly, Moderna's CEO has told Wall Street that COVID is "not leaving the planet" and that Moderna expects to sell annual booster shots for years to come. 6/ https://www.cnbc.com/2021/04/14/covid-vaccine-moderna-hopes-to-have-booster-shot-ready-by-the-fall-says-ceo.html
It doesn't have to be this way. As @zainrizvi & @Maybarduk ( @Public_Citizen @PCMedsAccess) explain, the Biden administration has law & policy at its disposal to mobilize, share, & build vaccine technology, & quickly supply the world with COVID vaccines. 7/ https://www.citizen.org/article/a-plan-for-the-peoples-vaccine/
@jbkrell ( @PrEP4AllNow), @peterstaley & Wafaa El-Sadr ( @ICAP_ColumbiaU) have laid out a plan of their own, under which the Biden admin could use a combination of carrots & sticks to partner with Moderna and get the world vaccinated within a year. 8/ https://www.nytimes.com/2021/01/12/opinion/world-covid-vaccines.html
As @jbkrell & @xianurrutia (also @PrEP4AllNow) have explained, manufacturing barriers can be overcome, for mRNA and other COVID vaccines. The world can make more vaccineâmuch moreâif we make a public investment in new capacity. 9/ https://www.prep4all.org/news/hit-hard-hit-fast-hit-globally
But before we can fully scale up public and global manufacturing of mRNA and other COVID vaccines, we need to convince the drug companies to share their "secret recipes"âtheir manufacturing processes, intermediates, samples, and so on. 10/
How to get drug companies to share their secrets? That's where we come in. @FT broke the news: Coauthors & I just published a brand-new report that explains how the US government could & should use a foundational government-owned patent as leverage. 11/ https://www.dropbox.com/s/1om1v1kagg7j9dn/NYU%20TLP%20Clinic%20Report%20on%20NIH%27s%20070%20Patent%2020210414%20%28FINAL%29.pdf?dl=0
My coauthors are 3 students in NYU's Technology Law & Policy Clinic: Laurel Boman ('21), Joe Rabinovitsj ('21), and Celine Rohr ('22). All did brilliant work, picking up the project mid-semester and tackling complex, detailed analysis of the relevant science and law. @Lawgeek 12/
Our reportâ"U.S. 10,960,070: The U.S. Governmentâs Important New Coronavirus Vaccine Patent"âexplains that scientists at @NIH & academic partners developed & patented foundational coronavirus vaccine technology. Moderna relies on it in every dose of vaccine it makes & sells. 13/
Not just Moderna but BioNTech, J&J, Novavax, & other leading vaccine candidates all rely on NIH's patented technology. As Dr. Tony Fauci just wrote in Science, "The speed and efficiency with which these highly efficacious vaccines were developed ... 14/ https://science.sciencemag.org/content/372/6538/109
... and their potential for saving millions of lives are due to an extraordinary multidisciplinary effort involving basic, preclinical, and clinical science that had been under wayâout of the spotlightâfor decades before the unfolding of the COVID-19 pandemic." 15/
Moderna relies on NIH's patented coronavirus vaccine technology, but (unlike BioNTech) it lacks NIH's permission to use that patented technology. That makes Moderna's manufacture & sale acts of patent infringement. And that means the US government could take Moderna to court. 16/
What's Moderna's potential liability, if/when the government sues for patent infringement? Based on public data & case law, my students & I estimate Moderna's liabilityâfor just its 2021 US sales alone!âcould range from a few hundred million dollars to well over a billion $$. 17/
Moderna's projected sales of its COVID vaccine in 2022 & beyond will incur additional liability. And NIH has a counterpart patent pending in Europe, which gives the US government even more leverage. In my view, Moderna faces multi-billion dollar liability in the long term. 18/
Would the US government ever actually take a drug company to court for infringing a government-owned patent? It already has: In 2019, HHS & DOJ sued Gilead for infringing the government's patents on HIV PrEP. That suit is ongoing. 19/ https://www.healthaffairs.org/do/10.1377/hblog20191118.218552/full/
The point, of course, is not for the government to maximize its financial returns on its patent. The point is to make NIH's patented coronavirus vaccine technology widely accessible, vaccinate the world, & defeat SARS-CoV-2. As we wrote in the report, @POTUS should ... 20/
"use the threat of litigation of the â070 patent to bring Moderna back to the negotiation table and convince Moderna to share its own patents, trade secrets, and other intellectual property on mRNA-1273 with the U.S. government and with vaccine manufacturers around the world."21/
My coauthors & I join an incredible coalition of civil society groups, scientists, & public health experts, calling on @POTUS @HHSGov @NIH to use the government's patent, alongside the Defense Production Act & other law & policy tools, to compel Moderna to share its secrets. 22/
Last month, that coalition sent a letter to the US govt, calling for action. @PrEP4AllNow, @Public_Citizen, @IMAKglobal, @HealthGAP, @HealthJusticeIn, @HIVpxresearch, Dr. Linda Fried, Dr. Cheryl Heaton, @MohandesDean, @MonicaGandhi9, ... 23/ https://www.washingtonpost.com/business/2021/03/25/moderna-vaccine-patent-nih/
... Dr. Adaora Adimora, @ChrisBeyrer, @chngin_the_wrld, @khmayer1, Dr. Wafaa El-Sadr, @CarlosdelRio7, Dr. John P. Moore, @gregggonsalves, @MMKavanagh, and David Barr all signed on to that letter (linked here). 24/ https://static1.squarespace.com/static/5e937afbfd7a75746167b39c/t/605c7d657cca1206e17b4d87/1616674150606/Moderna+and+the+%27070+Patent+24+March+2021.pdf
The question now is whether @POTUS @HHSGov @NIH will find the will to act. I'll close w/ words of Dr. Barney Grahamâeminent NIH scientist & one of the inventors who developed the (patented) coronavirus vaccine technology that Moderna now relies on. 25
Dr. Barney Graham: âItâs really up toâ .â.â. âthe political will and the use of public dollars to ask: are we going to use our technologies to solve these problems, and to solve them with global co-ordination, and with the recognition that we are all in this together?â 26/26
